ON-ICE trial: Investigation of the combined effects of oxytocin and naltrexone on stress-induced and alcohol cue-induced craving in alcohol use disorder-Study protocol of a phase II randomised double-blind placebo-controlled parallel-group trial

What Was Tested

The paper reports a study of Oxytocin, published as a clinical study.

Although alcohol dependence (AD) is highly prevalent, only few medications are approved for its treatment.

This trial has been approved by the ethics committee of Heidelberg University and competent authority.

Who Took Part

The study group was 62 participants.

Secondary outcomes include subjective stress, negative affect, cortisol and OXY plasma levels, and neural response to alcohol and emotional cues and natural rewards.

How the Study Was Run

In design terms this was a randomized, double-blind, placebo-controlled and parallel-group study.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

A placebo (an inactive look-alike) gave the Oxytocin group a baseline to be compared against.

The Oxytocin group and the comparison group ran side by side rather than switching.

The timeline in the abstract includes 90 days.

Follow-up drinking data were collected over 90 days.

Appropriate statistical analysis will be used for the evaluation of the secondary outcomes.

What Was Measured

The subject headings attached to it are Alcoholism, Clinical Trials, Phase II as Topic, Craving, Cues, Naltrexone, Neoplasm Recurrence, Local and Oxytocin.

Author keywords: MENTAL HEALTH, RADIOLOGY & IMAGING and Substance misuse.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Oxytocin in 62 participants over 90 days.

The publication is from 2022 (BMJ open), a journal based in England.

More context: the Oxytocin compound page, all human trials.